Erasca
Biotech
ClinicalTrialManager/SrClinicalTrialManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Clinical Trial Manager/Sr Clinical Trial Manager at Erasca. Skills: Clinical trial management, Oncology indications, Vendor management. Manage global clinical trials. Recruit global study sites”
Industry & Context.
What They're Looking For.
Must Have
5 years of relevant experience, 7 years of relevant experience, ICH-GCP guidelines experience, US and ex-US regulations experience, Electronic data capture experience, Data management software experience, Clinical Research Associates management experience, Reviewing monitoring trip reports experience
Nice to Have
Undergraduate degree in life sciences
What You'll Do.
Manage global clinical trials
Recruit global study sites
Foster relationships with study investigators
Participate in site selection
Participate in vendor selection
Participate in site qualification
Participate in vendor qualification
Participate in site activation
Develop Requests-for-Proposals
Assist in vendor selection efforts
Assist in review vendor contracts
Assist in negotiation vendor contracts
Assist in review study site agreements
Assist in negotiation study site agreements
Monitor trial progress
Track trial enrollment
Track clinical trial material inventory
Review monitoring visit reports
Assist in packaging clinical trial material
Assist in labeling clinical trial material
Assist in distribution clinical trial material
Monitor biological samples
Track biological samples
Provide progress updates to management
Provide progress updates during meetings
Assist in departmental budgeting
Assist in projections
Assist in development protocols
Assist in development consent forms
Assist in development IRB/EC materials
Assist in development trial documents
Assist in development Clinical SOPs
Prepare study materials
Review study materials
Approve study materials
Assist in electronic case report form design
Assist in electronic case report form development
Assist in IRT development
Participate in data cleaning
Develop appropriate data outputs
Fulfill needs of other Erasca departments
Provide leadership to team members
Perform duties in keeping with core values
Perform duties in keeping with policies
Perform duties in keeping with regulations
How You'll Work.
Team & Collaboration
Global multi-disciplinary teams; Program team meetings; Other Erasca departments
Communication Scope
Oral communication; Written communication
Process & Methodology
Clinical trial management, Project management, Priority management
Full Job Description
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer. The Clinical Trial Manager or Senior Clinical Trial Manager assists in the planning, implementation, and management of clinical studies from concept to completion. The position requires knowledge of clinical trial processes and prior experience in many aspects of trial execution from study start-up to study close-out, including assisting in the management of clinical vendors/CROs and assisting in the oversight of resources, budgets, contracts, and timelines. Essential Duties and Responsibilities: Manage global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements. Recruit global study sites and foster relationships with study investigators. Participate in the process of site and vendor selection, qualification, and activation. Develop Requests-for-Proposals and assist in vendor selection efforts. Assist in review and negotiation of vendor contracts and study site clinical trial agreements. Manage study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging). Monitor the progress of trials, including enrollment and clinical trial material inventory. Review monitoring visit reports for completeness and adherence to the annotations. Assist in packaging/labeling/distribution of clinical trial material. Monitor and track biological samples for applicable analyses. Provide progress upda
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